BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEPHYR XL DR

    MDR report key: 4140158 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-05940
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    November 10, 2011
    Manufacturer
    ST. JUDE MEDICAL, CRMD
    Product Code
    LWP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO WAS PROVIDED BY MFR, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS DIFFICULT TO INTERROGATE DURING FOLLOW UP. THE ERROR MESSAGE PRESENTED DURING AN INTERROGATION ATTEMPT STATED THAT THE DEVICE COULD NOT BE INTERROGATED BY MERLIN PCS. IT WAS SUGGESTED TO DOWNLOAD A NEW DEVICE CODE AND SOFTWARE. THE DEVICE REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33971 ZEPHYR XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, CRMD 5826

    Patients

    Seq Age Sex Outcome Treatment
    1